In 2002, the University of Maryland Marlene and Stewart Greenebaum Cancer Center (UMGCC) senior leadership team consisted of Sanford Stass, M.D., director; Barry Meisenberg, M.D., associate director for Clinical Research; Amy Fulton, Ph.D., associate director for Basic Science; and Mr. Mark Kochevar, associate director for Administration. Since 2003 there has been a complete reorganization of UMGCC, with recruitment of a new cadre of senior leaders. This change has been part of an overall restructuring at UMGCC, resulting in three full research programs and two developing recruitment programs, four full shared services and four developing shared services, and 41 new investigators. With these changes, there has been a dramatic increase in research activity and funding support. In 2003, UMGCC recruited Dr. Alan Tomkinson from the University of Texas Health Science Center at San Antonio to serve as the new associate director of Basic Science. He held a similar cancer center leadership position in Texas. Dr. Tomkinson is an internationally recognized expert in the field of DMA repair, and he oversees the basic research activities at UMGCC. Dr. Amy Fulton has moved to take on the leadership for the newly formed Hormone Responsive Cancers Program. In January 2004, Dr. Donald Wilson, dean of the University of Maryland School of Medicine (UMSOM), recruited Dr. Kevin Cullen as the new director of UMGCC. Dr. Cullen was previously professor of Medicine and Otolaryngology at the Lombardi Cancer Center of Georgetown University. He was acting director of that cancer center from 2000 to 2002 and was responsible for the successful recompetition of its P30 CCSG in 2002. Dr. Cullen's clinical and research interests are the molecular mechanisms of drug action and resistance in head and neck cancer. Drawing on his previous experience at the Lombardi Cancer Center, Dr. Cullen undertook the extensive reorganization of UMGCC after his arrival in January 2004. The reorganized structure of UMGCC is evident throughout this application. Dr. Cullen recruited Dr. Edward Sausville as associate director for Clinical Research in the summer of 2004. Dr. Sausville had previously been associate director of the Division of Cancer Treatment and Diagnosis of the National Cancer Institute (NCI), and in that capacity led NCI's Developmental Therapeutics Program. This role managed the preclinical drug discovery and development process for NCI-originated therapeutic agents. In addition, Dr. Sausville designed, implemented, and had administrative oversight of NCI's Rapid Access to Intervention Development Program and Rapid Access to NCI Discovery Program, which extended NCIcontract- based preclinical drug development resources to extramural investigators. Dr. Sausville is an internationally recognized authority on cancer drug development and early-phase clinical trial design. Since his arrival at UMGCC, Dr. Sausville has undertaken an extensive revision of UMGCC's clinical research apparatus. Dr. Meisenberg, the previous associate director for Clinical Research, is now chief of the division of Hematology/Oncology and continues his clinical research activities in bone marrow transplantation and other areas. Dr. Cullen also appointed Dr. Nicholas Ambulos director of Shared Services in 2004. Dr. Ambulos jointly serves as the director of the Biopolymer Shared Service, which is used extensively by investigators at UMGCC and UMSOM. Since 2004 he has overseen a reorganization of the shared services, including implementation of computerized order-entry and accounting systems, uniform governance for shared services, as well as strategic planning for implementation of new shared services and modification of existing ones. In 2005, Dr. Cullen appointed Dr. Mohan Suntharalingam to the newly created position of associate director for Clinical Services. Dr. Suntharalingam is vice chair of the Department of Radiation Oncology and is principal investigator (PI) for the University of Maryland's (UM's) Radiation Therapy Oncology Group (RTOG) grant. His clinical and research interests are aerodigestive cancers, and he has been the PI on numerous investigatorinitiated trials in head and neck cancer and other aerodigestive malignancies. Dr. Suntharalingam has administrative oversight of UMGCC's multidisciplinary clinical programs and has been instrumental in designing and implementing multidisciplinary clinics to facilitate patient care and clinical research. In 2006, Dr. Cullen recruited Mr. Stephen W. Long as the new associate director for Administration. Mr. Long has more than 37 years of experience in health administration in the Federal Government. He concluded a 28- year tenure in the senior administrative ranks of the National Institute on Alcohol Abuse and Alcoholism (NIAAA), serving as the executive officer of NIAAA for 8 years prior to his move to UMGCC. Mr. Long had administrative responsibility for both the intra- and extramural research programs of the NIAAA and also was a member of leadership at the National Institutes of Health (NIH), serving and/or chairing critical NIH committees on Ethics, the Office of Resource Services Council, and Senior Executive Service Search Committees, to mention a few of his responsibilities. Since his arrival at UMGCC, he has begun reorganizing the administrative structure of UMGCC, as well as its research operations. He has also been responsible for the oversight of significant expansion of UMGCC's laboratory facilities, and has also planned for extensive renovation of clinical and clinical research support facilities. Dr. Cullen recruited Ms. Laurene Mead as the senior administrator for Clinical Services in 2007. This newly created position provides administrative oversight of the outpatient and inpatient clinical operations at UMGCC. Ms. Mead previously held a similar leadership position at Greater Baltimore Medical Center, where she had oversight of cancer services, as well as women's health and professional services. Her primary responsibilities include the outpatient operations of UMGCC, which handles more than 24,000 outpatient visits and 12,000 infusion visits per year. UMGCC's leadership meets three times per month with program leaders as the Cancer Center Leadership Group (CCLG). This group is responsible for strategic planning, oversight of research and clinical operations, and approval of new faculty and senior-staff recruitments. Dr. Cullen meets separately each week with the senior administrative group, including Mr. Long; Ms. Mead; Susan Myers, director of Finance; Barry Meisenberg, chief of the Division of Hematology/Oncology; and Dr. Mohan Suntharalingam. These weekly administrative meetings deal with pressing operational issues and routine review of the financial status of UMGCC. As noted throughout this application, the reorganization of the senior leadership at UMGCC has been accompanied by a dramatic increase in the clinical research activities during the past 5 years. Since 2002 clinical activities have increased dramatically, while funding for cancer research has risen from $25.6 million annually to more than $47.1 million annually. Senior leadership has been responsible for developing and executing long-term vision and strategic planning for UMGCC, facilitating the NCI goal of reducing morbidity and mortality from cancer. In the last 5 years, UMGCC has emerged as a significant regional and national resource. It has become a major regional referral center for multidisciplinary cancer care, clinical trials, and specialized cancer treatment services. More important, UMGCC's investigators have changed the landscape of cancer treatment beyond the region, developing significantly improved cancer therapies that are now standard care worldwide